Quality assurance of pharmaceutical products has been defined and discussed in detail in the guide on GMP (2, pages 25-26).
The quality of dosage forms in Phase III clinical studies should be characterized and assured at the same level as for routinely manufactured products. The quality assurance system, designed, established and verified by the manufacturer, should be described in writing, taking into account the GMP principles to the extent that they are applicable to the operations in question. This system should also cover the interface between the manufacture and the trial site (e.g. shipment, storage, occasional additional labelling).